Process Modeling and Conformance Checking in Healthcare: A COVID-19 Case Study: Case Study

The discipline of process mining has a solid track record of successful applications to the healthcare domain. Within such research space, we conducted a case study related to the Intensive Care Unit (ICU) ward of the Uniklinik Aachen hospital in Germany. The aim of this work is twofold: developing a normative model representing the clinical guidelines for the treatment of COVID-19 patients, and analyzing the adherence of the observed behavior (recorded in the information system of the hospital) to such guidelines. We show that, through conformance checking techniques, it is possible to analyze the care process for COVID-19 patients, highlighting the main deviations from the clinical guidelines. The results provide physicians with useful indications for improving the process and ensuring service quality and patient satisfaction. We share the resulting model as an open-source BPMN file. © 2023, The Author(s).

Phase 3 RCT of C5a-Specific Vilobelimab in Severe COVID-19 Pneumonia

Background: Blocking the C5a-C5aR axis in COVID-19 patients could improve outcomes by limiting myeloid cell infiltration in damaged organs and preventing excessive lung inflammation and endothelialitis. Aims and Objectives: Vilobelimab (VILO), an anti-C5a mAb that preserves the membrane attack complex (MAC), was tested in a Phase III adaptively designed multicenter, double-blind placebo (P)-controlled study for survival in critically ill COVID-19 patients. Method(s): COVID-19 pneumonia patients (N=369;VILO n=178, P n=191) within 48 hrs of intubation were randomly assigned to receive 6, 800 mg infusions of VILO or P on top of standard of care. Primary outcome was 28-day allcause mortality. Result(s): 28-day all-cause mortality was 31.7% VILO vs 41.6% P (Kaplan-Meier estimates;Cox regression site stratified, HR 0.73;95%CI:0.50-1.06;P=0.094) with a 22.7% relative mortality reduction to Day 60. In predefined primary outcome analysis without site stratification, VILO significantly reduced 28-day mortality (HR 0.67;95%CI:0.48-0.96;P=0.027);needed to treat number, 10 to save 1. VILO significantly reduced 28-day mortality in severe patients with baseline WHO ordinal scale score of 7 (n=237, HR 0.62;95%CI:0.40-0.95;P=0.028) or severe ARDS/PaO2/FiO2<=100 mmHg (n=98, HR 0.55;95%CI:0.30-0.98;P=0.044) or eGFR<60 mL/min/1.73m2 (n=108, HR 0.55;95%CI:0.31-0.96;P=0.036). Treatment emergent AEs were 90.9% VILO vs 91.0% P. Infections were comparable;VILO (62.9%), P (59.3%). Serious AEs were 58.9% VILO, 63.5% P. Conclusion(s): VILO reduced mortality at 28 to 60 days in severe COVID-19 pneumonia patients with no increase in infections suggesting the importance of targeting C5a while preserving MAC.

Randomized, Controlled Phase 3 Study of anti-C5a Vilobelimab's Effect on Mortality in Critically Ill COVID-19 Patients: A Therapy for Viral Pneumonia

Background. SARS-CoV-2 induces endothelial damage and activates the complement system. In severe COVID-19 patients, complement split factor C5a is highly elevated leading to inflammation that contributes to multiorgan failure. The anti-C5a monoclonal antibody, Vilobelimab (Vilo), which preserves the membrane attack complex (MAC), was investigated in an adaptively designed, randomized doubleblind, placebo (P)-controlled Phase 3 international multicenter study for survival in critically ill COVID-19 patients (pts). Methods. COVID-19 pneumonia pts (N=368;Vilo n=177, P n=191), mechanically ventilated within 48 hrs before treatment, received up to 6, 800 mg infusions of Vilo or P on top of standard of care. The primary and main secondary endpoints were 28-day (d) and 60-d all-cause mortality. Results. Pts enrolled in the study were on corticosteroids (97%) and anticoagulants (98%) as standard of care. A smaller proportion (20%) were either continuing or had taken immunomodulators such as tocilizumab and baricitinib prior to receiving Vilo. The 28-d all-cause mortality was 31.7% with Vilo vs 41.6% with P (Kaplan-Meier estimates;Cox regression site-stratified, HR 0.73;95% CI:0.50-1.06;P=0.094), representing a 23.8% relative mortality reduction. In predefined primary outcome analysis without site stratification, however, Vilo significantly reduced mortality at 28 (HR 0.67;95% CI:0.48-0.96;P=0.027) and 60 days (HR 0.67;95% CI:0.48-0.92;P=0.016). Vilo also significantly reduced 28-d mortality in more severe pts with baseline WHO ordinal scale score of 7 (n=237, HR 0.62;95% CI:0.40-0.95;P=0.028), severe ARDS/PaO2/FiO2 <= 100 mmHg (n=98, HR 0.55;95% CI:0.30-0.98;P=0.044) and eGFR < 60 mL/min/1.73m2 (n=108, HR 0.55;95% CI:0.31-0.96;P=0.036). Treatment-emergent AEs were 90.9% Vilo vs 91.0% P. Infections were comparable: Vilo 62.9%, P 59.3%. Infection incidence per 100 Pt days were equal. No meningococcal infections were reported. Serious AEs were 58.9% Vilo, 63.5% P. Conclusion. Vilo significantly reduced mortality at 28 and 60 days in critically ill COVID-19 pts with no increase in infections suggesting the importance of targeting C5a while preserving MAC. Vilo targets inflammation which may represent an approach to treat sepsis and ARDS caused by other respiratory viruses. (Figure Presented).

Recommendations for treatment of critically ill patients with COVID-19 : Version 3 S1 guideline.

Since December 2019 a novel coronavirus (severe acute respiratory syndrome coronavirus 2, SARS-CoV-2) has rapidly spread around the world resulting in an acute respiratory illness pandemic. The immense challenges for clinicians and hospitals as well as the strain on many healthcare systems has been unprecedented.The majority of patients present with mild symptoms of coronavirus disease 2019 (COVID-19); however, 5-8% become critically ill and require intensive care treatment. Acute hypoxemic respiratory failure with severe dyspnea and an increased respiratory rate (>30/min) usually leads to intensive care unit (ICU) admission. At this point bilateral pulmonary infiltrates are typically seen. Patients often develop a severe acute respiratory distress syndrome (ARDS).So far, remdesivir and dexamethasone have shown clinical effectiveness in severe COVID-19 in hospitalized patients. The main goal of supportive treatment is to ascertain adequate oxygenation. Invasive mechanical ventilation and repeated prone positioning are key elements in treating severely hypoxemic COVID-19 patients.Strict adherence to basic infection control measures (including hand hygiene) and correct use of personal protection equipment (PPE) are essential in the care of patients. Procedures that lead to formation of aerosols should be carried out with utmost precaution and preparation.

Analyzing Medical Data with Process Mining: A COVID-19 Case Study

The recent increase in the availability of medical data, possible through automation and digitization of medical equipment, has enabled more accurate and complete analysis on patients’ medical data through many branches of data science. In particular, medical records that include timestamps showing the history of a patient have enabled the representation of medical information as sequences of events, effectively allowing to perform process mining analyses. In this paper, we will present some preliminary findings obtained with established process mining techniques in regard of the medical data of patients of the Uniklinik Aachen hospital affected by the recent epidemic of COVID-19. We show that process mining techniques are able to reconstruct a model of the ICU treatments for COVID patients. © 2022, Springer Nature Switzerland AG.

Extracorporeal membrane oxygenation in critically ill covid-19 patients and predictors of mortality: The aachen experience

The role of extracorporeal membrane oxygenation (ECMO) in the management of critically ill COVID-19patients remains unclear. Our study aims to analyze the outcomes and risk factors from patients treated with ECMO. Methods: This retrospective, single-center study includes seventeen COVID-19 patients treated with ECMO. Univariate andmultivariate parametric survival regression identified predictors of survival. Result: Nine patients (53%) were successfully weaned from ECMO and discharged. The incidence of in-hospital mortalitywas 47%. In a univariate analysis, only four out of 83 pre-ECMO variables were significantly different;IL-6, PCT, and NT-proBNP were significantly higher in non-survivors compared with survivors. The Respiratory Extracorporeal MembraneOxygenation Survival Prediction (RESP) score was significantly lower in survivors. After a multivariate parametric survivalregression, IL-6, NT-proBNP and RESP scores remained significant independent predictors, with hazard ratios (HR) of 1.069[95% CI: 0.986-1.160], p = 0.016 1.001 [95% CI: 1.000-1.001], p = 0.012;and 0.843 [95% CI: 0.564-1.260], p = 0.040,respectively. A prediction model consisting of IL-6, NT-proBNP, and RESP score showed an area under the curve (AUC) of0.87, with a sensitivity of 87.5% and specificity of 77.8%, compared with an AUC of 0.79 for the RESP score alone. Conclusion: The present study suggests that ECMO is a potentially lifesaving treatment for select critically ill COVID-19patients. Considering IL-6 and NT-per-BNP, in addition to the RESP score, may enhance outcome predictions.

Shelter characteristics, infection prevention practices, and universal testing for SARS-CoV-2 at homeless shelters in 7 US urban areas. (Special Section: COVID-19/public health preparedness and response.)

Objectives: To examine shelter characteristics and infection prevention practices in relation to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection point prevalence during universal testing at homeless shelters in the United States.

[S2k Guideline - Recommendations for Inpatient Therapy of Patients with COVID-19]. / S2k-Leitlinie ­ Empfehlungen zur stationären Therapie von Patienten mit COVID-19.

Since December 2019, the novel coronavirus SARS-CoV-2 (Severe Acute Respiratory Syndrome - Corona Virus-2) has been spreading rapidly in the sense of a global pandemic. This poses significant challenges for clinicians and hospitals and is placing unprecedented strain on the healthcare systems of many countries. The majority of patients with Coronavirus Disease 2019 (COVID-19) present with only mild symptoms such as cough and fever. However, about 6 % require hospitalization. Early clarification of whether inpatient and, if necessary, intensive care treatment is medically appropriate and desired by the patient is of particular importance in the pandemic. Acute hypoxemic respiratory insufficiency with dyspnea and high respiratory rate (> 30/min) usually leads to admission to the intensive care unit. Often, bilateral pulmonary infiltrates/consolidations or even pulmonary emboli are already found on imaging. As the disease progresses, some of these patients develop acute respiratory distress syndrome (ARDS). Mortality reduction of available drug therapy in severe COVID-19 disease has only been demonstrated for dexamethasone in randomized controlled trials. The main goal of supportive therapy is to ensure adequate oxygenation. In this regard, invasive ventilation and repeated prone positioning are important elements in the treatment of severely hypoxemic COVID-19 patients. Strict adherence to basic hygiene, including hand hygiene, and the correct wearing of adequate personal protective equipment are essential when handling patients. Medically necessary actions on patients that could result in aerosol formation should be performed with extreme care and preparation.

Familial intimacy and the ‘thing’ between us cuddle curtains and desires for detached relationality in Germany, Austria and Switzerland

During the government-imposed contact restrictions in Germany, Austria and Switzerland, older adults feared that they may no longer be able to experience physical contact with family members. They were, however, given hope by a ‘cuddle curtain’, a device that promised to enable familial intimacy while blocking the exposure of older bodies to the coronavirus. Our research team traced how one such artefact was used in nursing homes in Switzerland. Here, we discuss its cultural biography to explore notions of intimacy by relating discussions about the curtain to anthropological discussions about entanglement and detach-ment. We contrast positive associations between the curtain and familial intimacy with regu-lations surrounding body fluid barriers in sex work, in order to relate the ‘thing’ to the larger context within which it circulates. © Berghahn Books and the Association for Anthropology in Action.

[Perception of the COVID-19 Pandemic among Pneumology Professionals in Germany]. / Wahrnehmung der COVID-19-Pandemie unter pneumologischen Fachkräften in Deutschland.

The COVID-19 pandemic represents a huge burden on global health systems. Although far-reaching prevention measures such as the increase of intensive care capacities and drastic restrictions of public life have so far been able to avert an overload of the German health care system, the current situation implies an exceptionally high burden on medical professionals. The current study presents the results of an opinion evaluation among 513 pneumology specialists in Germany in the period from March 27th to April 11th, 2020. While the majority of respondents stated that Germany was "well" prepared for the pandemic, this assessment was significantly worse among participants from the outpatient sector compared to the hospital sector (p < 0.001). Furthermore, a lack of medical protective equipment was reported significantly more frequently by respondents from the outpatient sector (p < 0.001). The importance of telemedicine approaches during the COVID-19 pandemic was rated "high" (35.2 %) or "very high" (17.2 %) by most pneumology professionals, with participants from the hospital sector giving a higher rating (p < 0.001). Finally, 45.8 % of the respondents expressed a "negative" influence of the COVID-19 pandemic on their personal mood and 58.3 % expressed "strong" or "very strong" concerns about the health of their fellow human beings. This assessment was significantly stronger among female participants and participants from the nursing sector (p < 0.001). In summary, the current study analyses for the first time the professional and personal impact of the COVID-19 pandemic on pneumology professionals in Germany. The results could help to identify first starting points to better support health professionals during the current and future challenges.